High Risk Early-Stage Triple Negative Breast Cancer (TNBC) or Hormone Receptor Low Positive/Human Epidermal Growth Factor Receptor 2 Negative (HR-low+/HER2-) Breast Cancer
Conditions
Brief summary
Part 1: Number of Participants Experiencing an Adverse Event (AE), Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Part 2: Number of Participants Experiencing an Adverse Event (AE), Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
Detailed description
Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0, Part 2: Event-Free Survival (EFS), Part 2: Overall Survival (OS), Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Part 2: Residual Cancer Burden (RCB)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of Participants Experiencing an Adverse Event (AE), Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Part 2: Number of Participants Experiencing an Adverse Event (AE), Part 2: Number of Participants who Discontinued Study Treatment Due to an AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0, Part 2: Event-Free Survival (EFS), Part 2: Overall Survival (OS), Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Part 2: Residual Cancer Burden (RCB) | — |
Countries
Spain